EP3050560A4 - Intraorally disintegrable tablet comprising disintegrable granular composition - Google Patents

Intraorally disintegrable tablet comprising disintegrable granular composition Download PDF

Info

Publication number
EP3050560A4
EP3050560A4 EP14848881.0A EP14848881A EP3050560A4 EP 3050560 A4 EP3050560 A4 EP 3050560A4 EP 14848881 A EP14848881 A EP 14848881A EP 3050560 A4 EP3050560 A4 EP 3050560A4
Authority
EP
European Patent Office
Prior art keywords
disintegrable
intraorally
granular composition
tablet
disintegrable tablet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP14848881.0A
Other languages
German (de)
French (fr)
Other versions
EP3050560A1 (en
Inventor
Takahiro Hiramura
Kiyoshi Ikura
Sae Itaya
Tomohito Okabayashi
Anan Sakaguchi
Tetsuro Morita
Kimiko Ikeda
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daicel Corp
Original Assignee
Daicel Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Daicel Corp filed Critical Daicel Corp
Publication of EP3050560A1 publication Critical patent/EP3050560A1/en
Publication of EP3050560A4 publication Critical patent/EP3050560A4/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/166—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP14848881.0A 2013-09-27 2014-09-24 Intraorally disintegrable tablet comprising disintegrable granular composition Pending EP3050560A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2013202247 2013-09-27
PCT/JP2014/075228 WO2015046219A1 (en) 2013-09-27 2014-09-24 Intraorally disintegrable tablet comprising disintegrable granular composition

Publications (2)

Publication Number Publication Date
EP3050560A1 EP3050560A1 (en) 2016-08-03
EP3050560A4 true EP3050560A4 (en) 2017-04-05

Family

ID=52743355

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14848881.0A Pending EP3050560A4 (en) 2013-09-27 2014-09-24 Intraorally disintegrable tablet comprising disintegrable granular composition

Country Status (6)

Country Link
US (1) US20160213619A1 (en)
EP (1) EP3050560A4 (en)
JP (1) JP6302921B2 (en)
CN (1) CN105555262A (en)
TW (1) TWI644688B (en)
WO (1) WO2015046219A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9974738B2 (en) 2013-09-27 2018-05-22 Daicel Corporation Disintegrating particle composition produced by two-stage wet granulation process, and intraorally disintegrating tablet containing same composition
JP2017226600A (en) * 2014-10-16 2017-12-28 株式会社ダイセル Super fast disintegrating tablet

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1923074A1 (en) * 2005-08-10 2008-05-21 Shionogi & Co., Ltd. Orally disintegratable tablet
EP2465539A1 (en) * 2009-08-11 2012-06-20 Fuji Chemical Industry Co., Ltd. Disintegrating particle composition and orally rapidly disintegrating tablet
EP2832350A1 (en) * 2012-03-29 2015-02-04 Daicel Corporation Method for producing disintegrating particulate composition comprising acid-type carboxymethylcellulose, disintegrating particulate composition comprising acid-type carboxymethylcellulose, and orally disintegrating tablet including disintegrating particulate composition comprising acid-type carboxymethylcellulose
EP2898899A1 (en) * 2012-09-20 2015-07-29 Daicel Corporation Disintegrating particle composition containing acid-type carboxymethylcellulose and crystalline cellulose, and orally disintegrating tablet containing said composition

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4551627B2 (en) 2003-02-28 2010-09-29 東和薬品株式会社 Method for producing orally disintegrating tablets
KR100882156B1 (en) * 2003-08-08 2009-02-06 아지노모토 가부시키가이샤 Pharmaceutical preparation containing nateglinide
JP4567640B2 (en) * 2005-07-29 2010-10-20 田辺三菱製薬株式会社 Miniaturized sarpogrelate hydrochloride oral dosage form
CN101277721B (en) * 2005-08-10 2011-10-05 盐野义制药株式会社 Orally disintegrating tablet
EP1935405A1 (en) * 2006-12-22 2008-06-25 LEK Pharmaceuticals D.D. Orally disintegrating tablets
JP2008285434A (en) 2007-05-16 2008-11-27 Taisho Pharm Ind Ltd Quickly disintegrating tablet in oral cavity
EP2251005B1 (en) * 2008-02-13 2012-10-10 Dainippon Sumitomo Pharma Co., Ltd. Orally disintegrating tablets
KR101753411B1 (en) * 2008-11-25 2017-07-03 미쓰비시 타나베 파마 코퍼레이션 Orally rapidly disintegrating tablet, and process for producing same
JP6073543B2 (en) * 2010-07-08 2017-02-01 沢井製薬株式会社 Method for producing loratadine-containing orally disintegrating tablet
JP6245677B2 (en) * 2012-01-20 2017-12-13 ニプロ株式会社 Orally disintegrating tablets

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1923074A1 (en) * 2005-08-10 2008-05-21 Shionogi & Co., Ltd. Orally disintegratable tablet
EP2465539A1 (en) * 2009-08-11 2012-06-20 Fuji Chemical Industry Co., Ltd. Disintegrating particle composition and orally rapidly disintegrating tablet
EP2832350A1 (en) * 2012-03-29 2015-02-04 Daicel Corporation Method for producing disintegrating particulate composition comprising acid-type carboxymethylcellulose, disintegrating particulate composition comprising acid-type carboxymethylcellulose, and orally disintegrating tablet including disintegrating particulate composition comprising acid-type carboxymethylcellulose
EP2898899A1 (en) * 2012-09-20 2015-07-29 Daicel Corporation Disintegrating particle composition containing acid-type carboxymethylcellulose and crystalline cellulose, and orally disintegrating tablet containing said composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2015046219A1 *

Also Published As

Publication number Publication date
JP6302921B2 (en) 2018-03-28
US20160213619A1 (en) 2016-07-28
WO2015046219A1 (en) 2015-04-02
EP3050560A1 (en) 2016-08-03
CN105555262A (en) 2016-05-04
JPWO2015046219A1 (en) 2017-03-09
TWI644688B (en) 2018-12-21
TW201607567A (en) 2016-03-01

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